Inappropriate IP administration (dose/timing dispensing error)

Inappropriate IP Administration (Dose/Timing) Dispensing Error Table
Type of indicator Risk
Risk category Investigational Medicinal Product (IMP)
Golden KRI NO
Therapeutic area General
IF risk event The investigational product (IP) is not administered or dispensed correctly according to protocol specifications
DUE TO risk causes Misunderstanding of dosing or dispensing instructions, unclear protocol guidance, inadequate training, or site-specific procedural errors
THEN risk impact may result Potential harm to subjects, protocol deviations, and compromised data integrity, potentially affecting the study’s validity for efficacy and safety assessments
Risk indicator Inappropriate IP administration (dose/timing dispensing error)
Metric Percentage of incorrect IMP dispensations
Unit %
What level should be measured Study, country, site, subject
Purpose Detect and minimize dosing or timing errors in IP administration to ensure participant safety, adherence to protocol requirements, and preservation of data accuracy and reliability.
Description This KRI measures the proportion of IMP administrations that deviate from the correct dose or timing. Elevated rates may indicate site training gaps or protocol misinterpretations requiring corrective action.
Formula (Number of incidents of incorrect IP administration ÷ Total number of IP administrations) × 100%
Suggested thresholds - high 15%
Suggested thresholds - medium 10%
Associated metric 1 Number of incidents of incorrect IP administration
Associated metric 2 Total number of IP administrations
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